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A Randomized Trial of Induction Versus Expectant Management (ARRIVE)

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2015 by The George Washington University Biostatistics Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center Identifier:
First received: November 15, 2013
Last updated: October 19, 2015
Last verified: October 2015
Among nulliparous women with singleton uncomplicated term pregnancies, elective induction of labor at 39 weeks, compared with expectant management, reduces the risk of severe neonatal morbidity and perinatal mortality.

Condition Intervention
Labor and Delivery Procedure: Elective Induction of Labor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Induction in Nulliparous Women at 39 Weeks to Prevent Adverse Outcomes: A Randomized Controlled Trial

Further study details as provided by The George Washington University Biostatistics Center:

Primary Outcome Measures:
  • composite of severe neonatal morbidity and perinatal mortality [ Time Frame: delivery ]

    Composite includes any one of:

    • Antepartum, intrapartum, or neonatal death
    • Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiorespiratory support within first 72 hours
    • Apgar ≤ 3 at 5 minutes
    • Neonatal encephalopathy as defined by Shankaran et al.
    • Seizures
    • Sepsis. The diagnosis of sepsis will require the presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, cerebrospinal fluid (CSF), or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal X-ray confirming infection.
    • Pneumonia confirmed by X-ray or positive blood culture.
    • Meconium aspiration syndrome
    • Birth trauma (bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage facial nerve injury)
    • Intracranial hemorrhage or subgaleal hemorrhage
    • Hypotension requiring pressor support

Secondary Outcome Measures:
  • Cesarean delivery and indication [ Time Frame: delivery ]
  • Incisional extensions at cesarean section, including J shape or T shape; or cervical traumas [ Time Frame: delivery ]
  • Operative vaginal delivery and indication [ Time Frame: delivery ]
  • Chorioamnionitis, defined as a clinical diagnosis before delivery [ Time Frame: before delivery ]
  • Third or fourth degree perineal laceration [ Time Frame: delivery ]
  • Maternal death [ Time Frame: delivery ]
  • Admission to intensive care unit (ICU) [ Time Frame: delivery ]
  • Preeclampsia/gestational hypertension [ Time Frame: before delivery ]
  • Postpartum hemorrhage [ Time Frame: delivery ]

    defined as any of the following:

    • Clinical diagnosis of endometritis
    • Wound reopened for hematoma, seroma, infection or other reasons
    • Cellulitis requiring antibiotics
    • Pneumonia
    • Pyelonephritis
    • Bacteremia unknown source
    • Septic pelvic thrombosis

  • Maternal venous thromboembolism (deep venous thrombosis or pulmonary embolism) [ Time Frame: delivery ]
  • Birth weight, macrosomia > 4500 g, large for gestational age (LGA) defined as > 90th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data [ Time Frame: delivery ]
  • Duration of respiratory support including ventilator, CPAP, high-flow nasal cannula (HFNC) [ Time Frame: delivery ]
  • Small for gestational age defined as < 5th and < 10th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data [ Time Frame: delivery ]
  • Cephalohematoma [ Time Frame: delivery ]
  • Shoulder dystocia [ Time Frame: delivery ]
  • Transfusion of blood products or blood [ Time Frame: delivery ]
  • Hyperbilirubinemia requiring phototherapy or exchange transfusion [ Time Frame: delivery ]
  • Hypoglycemia (glucose < 40 mg%) requiring IV therapy [ Time Frame: delivery ]
  • Admission to neonatal intensive care unit (NICU) or intermediate care unit [ Time Frame: delivery ]
  • Number of clinic visits post randomization to admission for delivery [ Time Frame: randomization until delivery ]
  • ER/urgent care/triage visits post randomization to delivery [ Time Frame: randomization until delivery ]
  • Non-stress tests, biophysical profiles (BPPs), modified BPPs, ultrasounds done other than BPP, Doppler, contraction stress tests [ Time Frame: randomization until delivery ]
  • Epidural use [ Time Frame: delivery ]
  • Intrauterine pressure catheter (IUPC) or fetal scalp electrode placement [ Time Frame: delivery ]
  • Use of induction and ripening agents, maximum dose of oxytocin [ Time Frame: delivery ]
  • Antepartum hospital admission [ Time Frame: antepartum ]
  • Number of hours on the labor and delivery unit [ Time Frame: delivery ]
  • Maternal postpartum length of hospital stay [ Time Frame: after delivery ]
  • Neonatal length of hospital stay [ Time Frame: delivery ]
  • Length of neonatal intensive care unit or intermediate care stay [ Time Frame: delivery ]
  • Post discharge resource utilization including inpatient and outpatient visits for mother or baby [ Time Frame: discharge to 6 weeks ]

Estimated Enrollment: 6000
Study Start Date: March 2014
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Expectnant Management
Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
Elective Induction of Labor
Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days
Procedure: Elective Induction of Labor
Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score < 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Nulliparous - no previous pregnancy beyond 20 weeks
  2. Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.
  3. Gestational age at randomization between 38 weeks 0 days and 38 weeks 6 days inclusive based on clinical information and evaluation of the earliest ultrasound.

    Exclusion Criteria:

1. Project gestational age at date of first ultrasound is > 20 weeks 6 days 2. Plan for induction of labor prior to 40 weeks 5 days 3. Plan for cesarean delivery or contraindication to labor 4. Signs of labor (regular painful contractions with cervical change) 5. Fetal demise or known major fetal anomaly 6. Heparin or low-molecular weight heparin during the current pregnancy 7. Placenta previa, accreta, vasa previa 8. Active vaginal bleeding greater than bloody show 9. Ruptured membranes 10. Cerclage in current pregnancy 11. Known oligohydramnios, defined as amniotic fluid index (AFI) < 5 or maximum vertical pocket (MVP) < 2 12. Fetal growth restriction, defined as Estimated Fetal Weight (EFW) < 10th percentile 13. Known HIV positivity because of modified delivery plan 14. Major maternal medical illness associated with increased risk for adverse pregnancy outcome (for example, any diabetes mellitus, lupus, any hypertensive disorder, cardiac disease, renal insufficiency) 15. Refusal of blood products 16. Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality 17. Delivery planned elsewhere at a non-Network site

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01990612

Contact: Uma Reddy, MD, MPH 301-496-1074

United States, Alabama
University of Alabama - Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Stacy Harris, BSN    205-996-6262   
Principal Investigator: Alan TN Tita, MD         
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305-5317
Contact: Cynthia Willson, RN, BSN    650-724-6372   
Principal Investigator: Yasser El-Sayed, MD         
United States, Colorado
University of Colorado Recruiting
Denver, Colorado, United States, 80045
Contact: Kathy Hale, RN BSN    303-724-6685   
Principal Investigator: Ronald Gibbs, MD         
United States, Illinois
Northwestern University-Prentice Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Gail Mallett, RN BSN CCRC    312-503-3200   
Principal Investigator: William Grobman, MD         
United States, New York
Columbia University-St. Luke's Hospital Recruiting
New York City, New York, United States, 10032
Contact: Sabine Bousleiman, MSN    212-305-4348   
Principal Investigator: Ronald Wapner, MD         
United States, North Carolina
University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kelly Clark, RN    919-350-6117   
Principal Investigator: John M Thorp, Jr., MD         
Duke University Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Tammy S Bishop, RNC MSN    919-668-7475   
Principal Investigator: Geeta K Swamy, MD         
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44109
Contact: Wendy Dalton, RNC    216-778-7533   
Principal Investigator: Edward Chien, MD         
Ohio State University Hospital Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Francee Johnson, RN    614-293-5632   
Principal Investigator: Jay D Iams, MD         
United States, Rhode Island
Brown University Recruiting
Providence, Rhode Island, United States, 02905
Contact: Donna Allard, RNC    401-274-1122   
Principal Investigator: Dwight J Rouse, MD         
United States, Texas
Dept of OB/GYN, Southwestern Medical Center, University of Texas Recruiting
Dallas, Texas, United States, 75235-9032
Contact: Lisa Moseley, RN    214-648-2591   
Principal Investigator: Brian M Casey, MD         
University of Texas - Galveston Recruiting
Galveston, Texas, United States, 77555
Contact: Ashley Salazar, MSN    409-772-0312   
Principal Investigator: George R Saade, MD         
University of Texas - Houston Recruiting
Houston, Texas, United States, 77030
Contact: Felecia Ortiz, RN BSN    713-500-6467   
Principal Investigator: Baha Sibai, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Kim Hill, RN    801-585-7645   
Principal Investigator: Michael W Varner, MD         
Sponsors and Collaborators
The George Washington University Biostatistics Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Director: Uma Reddy, MD, MPH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Elizabeth Thom, PhD The George Washington University Biostatistics Center
Study Chair: William Grobman, MD Northwestern University
  More Information

Responsible Party: The George Washington University Biostatistics Center Identifier: NCT01990612     History of Changes
Other Study ID Numbers: HD36801-ARRIVE
Study First Received: November 15, 2013
Last Updated: October 19, 2015 processed this record on July 21, 2017